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Drug overview for TRULANCE (plecanatide):
Generic name: plecanatide (ple-KAN-a-tide)
Drug class: Irritable Bowel Syndrome Agents
Therapeutic class: Gastrointestinal Therapy Agents
Plecanatide, a guanylate cyclase-C (GC-C) agonist, stimulates secretion of chloride and bicarbonate into the intestinal lumen, which increases intestinal fluid and accelerates intestinal transit.
No enhanced Uses information available for this drug.
Generic name: plecanatide (ple-KAN-a-tide)
Drug class: Irritable Bowel Syndrome Agents
Therapeutic class: Gastrointestinal Therapy Agents
Plecanatide, a guanylate cyclase-C (GC-C) agonist, stimulates secretion of chloride and bicarbonate into the intestinal lumen, which increases intestinal fluid and accelerates intestinal transit.
No enhanced Uses information available for this drug.
DRUG IMAGES
TRULANCE 3 MG TABLET
The following indications for TRULANCE (plecanatide) have been approved by the FDA:
Indications:
Chronic idiopathic constipation
Constipation predominant irritable bowel syndrome
Professional Synonyms:
Constipation predominant IBS
Indications:
Chronic idiopathic constipation
Constipation predominant irritable bowel syndrome
Professional Synonyms:
Constipation predominant IBS
The following dosing information is available for TRULANCE (plecanatide):
The recommended adult dosage of plecanatide for the symptomatic treatment of chronic idiopathic constipation is 3 mg once daily. A dosage of 6 mg daily is not recommended; in clinical trials, the 6-mg daily dosage did not provide additional clinical benefit beyond that provided by the 3-mg daily dosage and was associated with an increased incidence of adverse effects.
Plecanatide is administered orally without regard to food. Although administration with a meal resulted in looser stools when compared with administration in the fasted state, plecanatide was administered with or without food in clinical trials. Plecanatide tablets should be swallowed whole.
Alternatively, for patients who are unable to swallow whole tablets, plecanatide tablets may be crushed and administered orally mixed in applesauce or dispersed in water and administered orally or via a nasogastric or gastric feeding tube. The manufacturer states that mixing crushed plecanatide tablets in soft foods other than applesauce or dispersing the tablets in liquids other than water has not been studied. If a dose of plecanatide is missed, a double dose should not be administered to make up for the missed dose.
The next dose should be taken at the regularly scheduled time. For administration in applesauce, a plecanatide 3-mg tablet should be crushed to a powder and mixed with one teaspoonful of room-temperature applesauce in a clean container. The entire mixture should be consumed immediately and should not be stored for later use.
For oral administration as an aqueous dispersion, a plecanatide 3-mg tablet should be placed in a clean cup, approximately 30 mL of room-temperature water should then be added to the cup, and the mixture should be gently swirled for at least 10 seconds to disperse the disintegrating tablet. The entire mixture should be consumed immediately. Any residue remaining in the cup should be dispersed in an additional 30 mL of water, gently swirled again for at least 10 seconds, and then consumed immediately.
The mixture should not be stored for later use. For administration via nasogastric or gastric feeding tube, a plecanatide 3-mg tablet should be placed in a clean cup, approximately 30 mL of room-temperature water should be added to the cup, and the mixture should be gently swirled for at least 15 seconds to disperse the disintegrating tablet. The nasogastric or gastric feeding tube should be flushed with 30 mL of water and then the entire contents of the mixture should be drawn up into a syringe and administered immediately.
Any residue remaining in the cup should be dispersed in an additional 30 mL of water, gently swirled again for at least 15 seconds, and then administered via the nasogastric or gastric feeding tube using the same syringe. Following administration of the dose, the nasogastric or gastric feeding tube should be flushed with at least 10 mL of water using either the same syringe or a new syringe. The mixture should not be stored for later use.
Alternatively, for patients who are unable to swallow whole tablets, plecanatide tablets may be crushed and administered orally mixed in applesauce or dispersed in water and administered orally or via a nasogastric or gastric feeding tube. The manufacturer states that mixing crushed plecanatide tablets in soft foods other than applesauce or dispersing the tablets in liquids other than water has not been studied. If a dose of plecanatide is missed, a double dose should not be administered to make up for the missed dose.
The next dose should be taken at the regularly scheduled time. For administration in applesauce, a plecanatide 3-mg tablet should be crushed to a powder and mixed with one teaspoonful of room-temperature applesauce in a clean container. The entire mixture should be consumed immediately and should not be stored for later use.
For oral administration as an aqueous dispersion, a plecanatide 3-mg tablet should be placed in a clean cup, approximately 30 mL of room-temperature water should then be added to the cup, and the mixture should be gently swirled for at least 10 seconds to disperse the disintegrating tablet. The entire mixture should be consumed immediately. Any residue remaining in the cup should be dispersed in an additional 30 mL of water, gently swirled again for at least 10 seconds, and then consumed immediately.
The mixture should not be stored for later use. For administration via nasogastric or gastric feeding tube, a plecanatide 3-mg tablet should be placed in a clean cup, approximately 30 mL of room-temperature water should be added to the cup, and the mixture should be gently swirled for at least 15 seconds to disperse the disintegrating tablet. The nasogastric or gastric feeding tube should be flushed with 30 mL of water and then the entire contents of the mixture should be drawn up into a syringe and administered immediately.
Any residue remaining in the cup should be dispersed in an additional 30 mL of water, gently swirled again for at least 15 seconds, and then administered via the nasogastric or gastric feeding tube using the same syringe. Following administration of the dose, the nasogastric or gastric feeding tube should be flushed with at least 10 mL of water using either the same syringe or a new syringe. The mixture should not be stored for later use.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TRULANCE 3 MG TABLET | Maintenance | Adults take 1 tablet (3 mg) by oral route once daily |
No generic dosing information available.
The following drug interaction information is available for TRULANCE (plecanatide):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Trofinetide/Laxatives SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Trofinetide commonly causes diarrhea of mild to moderate severity. Laxatives may increase the incidence or severity of diarrhea.(1) CLINICAL EFFECTS: Concurrent use of laxatives with trofinetide may increase the risk of severe diarrhea.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients should stop laxatives before starting trofinetide. If diarrhea occurs, consider anti-diarrheal treatment and monitor hydration status. If severe diarrhea or dehydration occurs, interrupt, reduce dose, or discontinue trofinetide.(1) DISCUSSION: In clinical trials, 85% of patients on trofinetide developed diarrhea. Concurrent use of laxatives may increase this risk.(1) |
DAYBUE |
| Tenapanor/Laxatives; Stool Softeners SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Tenapanor commonly causes diarrhea of mild to moderate severity. Laxatives and stool softeners may increase the incidence or severity of diarrhea.(1) CLINICAL EFFECTS: Concurrent use of laxatives or stool softeners with tenapanor may increase the risk of severe diarrhea.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of tenapanor states that patients should be instructed to avoid stool softeners and laxatives with tenapanor. If severe diarrhea occurs, tenapanor should be discontinued.(1) DISCUSSION: In clinical trials, 43-53% of CKD patients on dialysis treated with tenapanor developed diarrhea. Diarrhea usually occurred soon after treatment initiation and was severe in 5% of patients.(1) |
XPHOZAH |
There are 0 moderate interactions.
The following contraindication information is available for TRULANCE (plecanatide):
Drug contraindication overview.
Plecanatide is contraindicated in infants and children younger than 6 years of age. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.) The drug also is contraindicated in any patient with known or suspected mechanical GI obstruction.
Plecanatide is contraindicated in infants and children younger than 6 years of age. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.) The drug also is contraindicated in any patient with known or suspected mechanical GI obstruction.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Gastrointestinal obstruction |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for TRULANCE (plecanatide):
Adverse reaction overview.
Diarrhea was reported in 5% of patients with chronic idiopathic constipation receiving plecanatide 3 mg daily and more frequently with the drug than with placebo.
Diarrhea was reported in 5% of patients with chronic idiopathic constipation receiving plecanatide 3 mg daily and more frequently with the drug than with placebo.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests |
There are 14 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea |
Dizziness Nausea Pharyngitis Urinary tract infection |
| Rare/Very Rare |
|---|
|
Abdominal distension Acute abdominal pain Flatulence Pruritus of skin Sinusitis Skin rash Upper respiratory infection Urticaria Vomiting |
The following precautions are available for TRULANCE (plecanatide):
Plecanatide is contraindicated in infants and children younger than 6 years of age and should be avoided in children and adolescents 6 years to younger than 18 years of age. Safety and efficacy of plecanatide in pediatric patients younger than 18 years of age have not been established, and the drug has caused deaths within 24 hours of administration in toxicology studies in juvenile mice (age approximately equivalent to a human age of 1 month to younger than 2 years). The deaths in young juvenile mice occurred following single oral doses of plecanatide 0.5
and 10 mg/kg administered on postnatal days 7 and 14, respectively. The deaths apparently were due to dehydration resulting from increased fluid secretion into the intestine as a consequence of guanylate cyclase-C (GC-C) stimulation. Because of increased intestinal expression of GC-C, infants and children younger than 6 years of age may be at greater risk of developing diarrhea and its potentially serious consequences compared with individuals 6 years of age and older.
Although no deaths were observed in older juvenile mice, use of plecanatide should be avoided in children and adolescents 6 years to younger than 18 years of age because of the deaths reported in younger mice and the lack of safety and efficacy data in pediatric patients. Although administration of the recommended plecanatide dosage (approximately 0.05 mg/kg daily in a 60-kg individual) in adults does not result in measurable plasma concentrations of the drug, systemic absorption was observed in juvenile animal toxicology studies; animal and human doses should not be compared directly for evaluating relative exposure.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
and 10 mg/kg administered on postnatal days 7 and 14, respectively. The deaths apparently were due to dehydration resulting from increased fluid secretion into the intestine as a consequence of guanylate cyclase-C (GC-C) stimulation. Because of increased intestinal expression of GC-C, infants and children younger than 6 years of age may be at greater risk of developing diarrhea and its potentially serious consequences compared with individuals 6 years of age and older.
Although no deaths were observed in older juvenile mice, use of plecanatide should be avoided in children and adolescents 6 years to younger than 18 years of age because of the deaths reported in younger mice and the lack of safety and efficacy data in pediatric patients. Although administration of the recommended plecanatide dosage (approximately 0.05 mg/kg daily in a 60-kg individual) in adults does not result in measurable plasma concentrations of the drug, systemic absorption was observed in juvenile animal toxicology studies; animal and human doses should not be compared directly for evaluating relative exposure.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Since systemic absorption of plecanatide and its active metabolite is negligible following oral administration, the drug is not expected to result in fetal exposure if administered to pregnant women. However, available data on use of plecanatide in pregnant women are insufficient to inform fetal risk. No adverse effects on embryofetal development were observed in mice or rabbits when plecanatide was administered orally during organogenesis at dosages up to 800 or 250 mg/kg daily, respectively.
In addition, no developmental abnormalities and no effects on growth, learning and memory, or fertility were observed in the offspring of mice that received plecanatide orally at dosages up to 600 mg/kg daily during the period of organogenesis through lactation. Limited systemic exposure to plecanatide was achieved in rabbits during the period of organogenesis. Animal and human doses should not be compared directly for evaluating relative exposure.
In addition, no developmental abnormalities and no effects on growth, learning and memory, or fertility were observed in the offspring of mice that received plecanatide orally at dosages up to 600 mg/kg daily during the period of organogenesis through lactation. Limited systemic exposure to plecanatide was achieved in rabbits during the period of organogenesis. Animal and human doses should not be compared directly for evaluating relative exposure.
It is not known whether plecanatide is distributed into human milk, affects milk production, or affects the breast-fed infant. Systemic absorption of plecanatide and its active metabolite is negligible following oral administration. It is not known whether the negligible systemic absorption observed in adults will result in clinically important exposure in breast-fed infants.
The benefits of breast-feeding and the importance of plecanatide to the woman should be considered along with potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. Exposure of infants to plecanatide could result in serious adverse effects. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
The benefits of breast-feeding and the importance of plecanatide to the woman should be considered along with potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. Exposure of infants to plecanatide could result in serious adverse effects. (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
Clinical trials of plecanatide did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults. In clinical trials in patients with chronic idiopathic constipation, 10% of patients were 65 years of age and older, while 2% were 75 years of age and older. Because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly, dosage selection for geriatric patients should be cautious.
The following prioritized warning is available for TRULANCE (plecanatide):
WARNING: This medication must not be used by children younger than 6 years. It is not recommended for use in children 6 to less than 18 years due to the risk for harm (especially serious dehydration). Talk to your doctor for details.
WARNING: This medication must not be used by children younger than 6 years. It is not recommended for use in children 6 to less than 18 years due to the risk for harm (especially serious dehydration). Talk to your doctor for details.
The following icd codes are available for TRULANCE (plecanatide)'s list of indications:
| Chronic idiopathic constipation | |
| K59.04 | Chronic idiopathic constipation |
| Constipation predominant irritable bowel syndrome | |
| K58.1 | Irritable bowel syndrome with constipation |
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